A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Associated Cervical Neoplasia
Biological: HPV-16/18 L1 VLP AS04
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years|
- Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Month 7 ] [ Designated as safety issue: No ]
- Occurrence of SAEs [ Time Frame: Throughout the study period (up to Month 7) ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms [ Time Frame: During the 7 days after each and any vaccination ] [ Designated as safety issue: No ]
- Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: No ]
- Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the study period (up to Month 7) ] [ Designated as safety issue: No ]
- Anti-HPV-16/18 antibody titres (by ELISA) [ Time Frame: At Month 0 and Month 7 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
The protocol was primarily amended for the following reason:
Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.